The Harbor MedTech BriDGE Extracellular Collagen Matrix Wound Dressing is indicated for the local management of moderately to heavy exuding wounds, including:

Partial and full thickness wounds, .
Draining wounds, .
Pressure sores/ulcers. .
Venous ulcers, ●
Chronic vascular ulcers, .
Diabetic ulcers, .
Trauma wounds (e.g., abrasions, lacerations, partial thickness burns, skin tears),
Surgical wounds (e.g., donor sites/grafts, post-laser surgery, post-Mohs surgery, podiatric . wounds, dehisced surgical incisions)

Device Description

The Harbor MedTech BriDGE Extracellular Collagen Matrix (ECM) Wound Dressing is a decellularized equine pericardial device that has been stabilized and radiation sterilized. The BriDGE ECM is non-pyrogenic and is provided sterile for single use only. The device must be rehydrated and rinsed prior to use following the procedure described in the Instructions for Use.

The BriDGE ECM is available in four sizes. The BriDGE ECM is available as a standard dressing and in a fenestrated model with pre-cut slits in the collagen matrix.

AI/ML Overview

The provided text describes the acceptance criteria and study for the Harbor MedTech BriDGE Extracellular Collagen Matrix Wound Dressing.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the BriDGE Extracellular Collagen Matrix Wound Dressing were primarily established through biocompatibility testing and material testing (tensile strength and suture pull-out testing) to demonstrate substantial equivalence to predicate devices. The reported device performance is indicated by the "Pass" status for biocompatibility tests and comparative results for material testing.

Test Category	Specific Test	Acceptance Criteria (Implied by "Pass" or "Equivalent/Stronger")	Reported Device Performance
Biocompatibility	Cytotoxicity (ISO Elution Method)	Non-toxic	Pass - non-toxic
	Genotoxicity (Mouse Lymphoma Assay)	Non-mutagenic	Pass - non-mutagenic
	Systemic Toxicity (ISO Study in Mice)	Non-toxic	Pass - non-toxic
	Intracutaneous (ISO Study in Rabbits)	Non-irritant	Pass - non-irritant
	Sensitization (ISO Guinea Pig Maximization)	Non-sensitizing	Pass - non-sensitizing
	Mouse Peripheral Blood Micronucleus Study	No micronuclei	Pass - no micronuclei in mice
	Bacterial Reverse Mutation Study	Non-mutagenic	Pass - non-mutagenic
	Rabbit Pyrogen (USP Material Mediated)	Non-pyrogen	Pass - non-pyrogen
Material Testing	Tensile Strength (compared to predicate devices: Unite Biomatrix and Oasis Wound Matrix)	Equivalent or stronger than predicate devices	Equivalent to Unite Biomatrix, significantly stronger than Oasis Wound Matrix (non-fenestrated and fenestrated comparable to non-fenestrated BriDGE ECM and stronger than Oasis non-fenestrated)
	Suture Pull-Out Testing (compared to predicate devices)	Equivalent to predicate devices	Equivalent to predicate devices

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not explicitly state the exact sample sizes for each of the performance and biocompatibility studies. The studies are described as "A study" or "Complete biocompatibility studies," indicating that samples were used, but the specific number of units, animals, or specimens is not detailed.
Data Provenance: The biocompatibility studies were conducted by NAmSA under Good Laboratory Practices (GLP) in accordance with ISO 10993 standards. The material testing (tensile strength and suture pull-out) was conducted presumably by or for Harbor MedTech, Inc. The document does not specify the country of origin of the data beyond mentioning NAmSA as the testing facility. All studies described are preclinical studies, implying they were conducted in a controlled lab environment rather than on human subjects. They are prospective in nature, designed specifically to evaluate the device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the studies described are preclinical performance and biocompatibility tests, not studies that require expert-established ground truth in the context of medical imaging or clinical diagnostics. The "ground truth" here is defined by objective laboratory measurements and standardized biological responses, as determined by the GLP-adhering personnel at NAmSA and in material testing labs.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as #3. Adjudication methods like 2+1 or 3+1 are used in clinical studies or expert reviews to resolve disagreements, which is not relevant to laboratory-based material or biocompatibility testing.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This information is not applicable. The device described is a wound dressing, not an AI-powered diagnostic or imaging tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. The device is a physical wound dressing, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for the performance testing includes:

Standardized biological responses: For biocompatibility tests (e.g., cell viability for cytotoxicity, mutation rates for genotoxicity, inflammatory responses for irritation/sensitization). These are established by international standards (ISO 10993, OECD Test No. 474) and assessed under GLP conditions.
Objective physical measurements: For material testing (e.g., peak load in Newtons for tensile strength and suture pull-out). These are quantitative measurements against established material properties.
Predicate device comparison: The performance of the BriDGE ECM was directly compared to the performance of legally marketed predicate devices (Unite™ Biomatrix and Oasis Wound Dressing) to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical wound dressing and does not involve AI or machine learning, thus no "training set" in the computational sense is used. The manufacturing process and formulation could be considered "trained" through iterative development, but this is not quantifiable as a typical training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as #8.

Summary

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FEB 2 6 2013

510(k) SUMMARY K122502 Harbor MedTech, Inc. BriDGE Extracellular Collagen Matrix Wound Dressing

ADMINISTRATIVE INFORMATION:

Manufacturer Name:

Harbor MedTech, Inc. 4 Jenner, Suite 190 Irvine, CA 92618 (949) 679-4800 Telephone: Facsimile: (949) 679-1086 Email: jerrym@harbormedtech.com

Official Correspondent:

Jerry Mezger, Chief Executive Officer

Additional Correspondent:

Carol White, QA/RA Consultant 21521 Hummingbird Street Trabuco Canyon, CA 92679 (949) 874-2024 Telephone: Facsimile: (949) 589-0442 Email: carolwhite@cox.net

DEVICE NAME AND CLASSIFICATION

BriDGE Extracellular Collagen Matrix Wound Dressing Trade/Proprietary Name: Common Name: Dressing, Wound, Collagen Classification Regulation: Unclassified Product Code: KGN Device Class: Unclassified Review Panel: General & Plastic Surgery

INTENDED USE

The Harbor MedTech BriDGE Extracellular Collagen Matrix Wound Dressing is indicated for the local management of moderately to heavy exuding wounds, including:

Partial and full thickness wounds, .
Draining wounds, .
Pressure sores/ulcers. .
Venous ulcers, ●
Chronic vascular ulcers, .
Diabetic ulcers, .
Trauma wounds (e.g., abrasions, lacerations, partial thickness burns, skin tears),

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Surgical wounds (e.g., donor sites/grafts, post-laser surgery, post-Mohs surgery, podiatric . wounds, dehisced surgical incisions)

DEVICE DESCRIPTION

The BriDGE ECM is available in four sizes. The BriDGE ECM is available as a standard dressing and in a fenestrated model with pre-cut slits in the collagen matrix. A table of proposed model numbers and sizes is provided below:

Model Number	Dimensions	Description
HMT009	3 cm x 3 cm	Standard
HMT036	6 cm x 6 cm	Standard
HMT100	10 cm x 10 cm	Standard
HMT150	10 cm x 15 cm	Standard
HMT009F	3 cm x 3 cm	Fenestrated
HMT036F	6 cm x 6 cm	Fenestrated
HMT100F	10 cm x 10 cm	Fenestrated
HMT150F	10 cm x 15 cm	Fenestrated

EQUIVALENCE TO MARKETED PRODUCT

Harbor MedTech, Inc., demonstrated that, for purposes of FDA's regulation of medical devices, the BriDGE Extracellular Collagen matrix (ECM) Wound Dressing is substantially equivalent in indications and design principles to predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices.

The Harbor MedTech BriDGE ECM Wound Dressing is substantially equivalent to the following predicate devices: Pegasus Biologics Inc., Unite™ Biomatrix Collagen Wound Dressing K071425, and Cook Biotech, Inc., Oasis Wound Dressing K061711.

The BriDGE Extracellular Collagen Matrix Wound Dressing has the same intended use as the predicate devices and incorporates the same basic design. The proposed device and the predicate devices are available as sheets in multiple sizes and are either sold pre-fenestrated (Pegasus) or may be fenestrated by the physician (Oasis). The BriDGE ECM undergoes a lyophilization process during manufacturing as does the Oasis predicate device. Device stabilization of the BriDGE ECM is achieved by using BDDGE, whereas the Pegasus predicate device uses EDC and the Oasis predicate device process is unknown. The BriDGE ECM and the Pegasus predicate device utilize equine pericardium and the Oasis predicate device utilizes porcine SIS.

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PERFORMANCE TESTING

A number of preclinical studies were conducted to assess the physical attributes of the collagen biomaterial and manufacturing processing. Complete biocompatibility studies were conducted on the material. Results of all performance tests were found to be acceptable. The BriDGE Extracellular Collagen Matrix Wound Dressing is as safe and as effective as the predicate devices.

Biocompatibility testing was performed under Good Laboratory Practices (GLP) by NAmSA in accordance with the relevant parts of ISO 10993 Biological Evaluation of Medical Devices. All GLP testing met the criteria for biocompatibility. The testing criteria followed were based on the following medical device categorization: surface device, breached or compromised surface, prolonged contact (>24h to ≤30 days).

Biocompatibility Summary - BriDGE Extracellular Collagen Matrix
CytotoxicityISO Elution Method	ISO 10993-5	Pass - non-toxic
GenotoxicityMouse Lymphoma Assay	ISO 10993-3	Pass - non-mutagenic
Systemic ToxicityISO Study in Mice	ISO 10993-11	Pass - non-toxic
IntracutaneousISO Study in Rabbits	ISO 10993-10	Pass - non-irritant
SensitizationISO Guinea Pig Maximization	ISO 10993-10	Pass - non-sensitizing
Mouse Peripheral BloodMicronucleus Study	OECD Test No. 474	Pass - no micronuclei in mice
Bacterial Reverse Mutation Study	ISO 10993-3	Pass - non-mutagenic
Rabbit PyrogenUSP Material Mediated	ISO 10993-11	Pass - non-pyrogen

The following table summarizes the material testing performed.

Tensile Strength Testing

A study was conducted to compare the ultimate tensile strength of the BriDGE ECM to the predicate devices: Unite Biomatrix and Oasis Wound Matrix. Samples were rehydrated and pull tested for peak load (N). The tensile strength of the BriDGE ECM was equivalent to the Unite Biomatrix and significantly stronger than the Oasis Wound Matrix samples.

A study was conducted to determine the functional tensile strength characteristics of the fenestrated version of the BriDGE Extracellular Collagen Matrix. Samples were rehydrated and pull tested for peak load (N). The results were compared to the tensile strength data collected for the standard BriDGE Extracellular Collagen Matrix (non-fenestrated). The samples were pulled both vertically and horizontally. The results of the testing showed that the fenestrated

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BriDGE ECM samples were comparable to the non-fenestrated BriDGE ECM samples and stronger than the Oasis Wound Matrix non-fenestrated samples.

Suture Pull-Out Testing

The BriDGE ECM was tested to characterize the device in terms of suture pull out resistance. The samples were hydrated and a 4-0 Prolene suture was attached and pull tested for peak load (N). Comparison testing was performed using samples of the predicate devices: Unite Biomatrix and Oasis Wound Dressing. The BriDGE ECM was found to be equivalent to the predicate devices in terms of suture pull-out strength.

Based on the results of the performance bench testing and comparison to predicate devices, Harbor MedTech has demonstrated that the BriDGE Extracellular Collagen Matrix Wound Dressing is equivalent to the predicate devices in terms of performance characteristics and will perform as intended for the application of the product.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with outstretched wings.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Harbor Medtech, Incorporated % Mr. Jerry Mezger Chief Executive Officer 4 Jenner, Suite 190 Irvine, California 92618

February 26, 2013

Re: K122502

Trade/Device Name: Bridge Extracellular Collagen Matrix Regulation Number: Unclassified Regulation Name: Dressing, Wound Collagen Regulatory Class: Unclassified Product Code: KGN Dated: January 29, 2013 Received: February 25, 2013

Dear Mr. Mezger:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 - Mr. Jerry Mezger

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Peter Diffillimm -S

FOR

Mark N. Meikerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Premarket Notification

BriDGE Extracellular Collagen Matrix Wound Dressing

INDICATIONS FOR USE

510(k) Number (if known): K122502

Device Name:

BriDGE Extracellular Collagen Matrix Wound Dressing

Indications for Use:

The Harbor MedTech BriDGE Extracellular Collagen Matrix Wound Dressing is indicated for the local management of moderately to heavy exuding wounds, including:

Partial and full thickness wounds, .
. Draining wounds,
. Pressure sores/ulcers,
Venous ulcers, .
Chronic vascular ulcers, .
. Diabetic ulcers,
Trauma wounds (e.g., abrasions, lacerations, partial thickness burns, skin tears), .
Surgical wounds (e.g., donor sites/grafts, post-laser surgery, post-Mohs surgery, podiatric . wounds, dehisced surgical incisions)

X Prescription Use (21 CFR 801 Subpart D)

and/or

Over-the-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jiyoung Dang

(Division Sign-Off) Division of Surgical Devices 510(k) Number K122502

Regulation Number and Section

N/A